AB1103 UPADACITINIB REAL-LIFE EFFICACY AND SAFETY IN PSORIATIC ARTHRITIS: RESULTS AT 24 WEEKS OF A MULTICENTRIC ITALIAN STUDY (UP-REAL)
Authors: V. Paci, M. M. Luchetti, A. Carletto, A. Zabotti, N. Luciano, R. Ramonda, L. Dagna, G. Sandri, C. Salvarani, M. S. Chimenti, N. Possemato, A. Piccinelli, I. Giovannini, G. Striani, N. Boffini, I. Pantano, D. Benfaremo, F. Ciccia, C. Selmi, G. Moroncini
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Psoriatic arthritis (PsA) is a chronic systemic inflammatory musculoskeletal disease whose heterogeneous manifestations are classified in multiple domains; moreover, PsA negatively influence many comorbid diseases.<sup>[1]</sup> As growing evidence suggests, it is important to research drugs active on multiple domains, trying to target therapy for every PsA manifestations. Upadacitinib (UPA) is a selective JAK inhibitor effective in many PsA domains according to randomized controlled trials.<sup>[2]</sup> However, real-world data on UPA performance in everyday clinical practice are currently lacking. <h3>Objectives</h3> This observational study aims to evaluate real-life efficacy and safety of UPA in the treatment of PsA in a large multicentre cohort. Secondary objectives are: <b>a.</b> to obtain the ideal patient profile for UPA therapy; <b>b.</b> to stratify clinimetric and laboratoristic responses according to patient manifestation and comorbidities. <h3>Methods</h3> Patients with either peripheral and/or axial PsA, classified according to CASPAR and ASAS criteria, who initiated UPA by clinical indication were enrolled at 10 Italian centers according to the following inclusion criteria: 1a. failure or intolerance towards at least one csDMARD for bio-naïve patients, or 1b. failure of at least one bDMARD for bio-failure patients; 2. active PsA disease, defined according to treat-to-target strategy by the absence of MDA (Minimal Disease Activity); 3. age &gt; 18 years. Patients were assessed at baseline (T0) and at week 12 (T3) and 24 (T6), recording responses in the main clinimetric indices (i.e. TJC, SJC, LEI, DAPSA, ASDAS-CRP, MDA &amp; VLDA) and a complete laboratory panel. Any type of adverse event was recorded at each visit. Data about assessment until week 56 (T12) for all patients will be presented in a future work. <h3>Results</h3> A total of 126 patients, 73 (69.5%) females and 32 (30.5%) males, started therapy with UPA: mean age 55.9±11.2 years, mean BMI 26.8±5.1, mean duration of disease 114.7±100.9 months. Most patients (n.124, 98.4%) show peripheral joint involvement: n.39 (31.4%) with oligoarticular and n.85 (68.6%) with polyarticular pattern. Axial involvement was found in n.56 (44.4%) patients. Most patients (n.89, 70.6%) had failed at least 1 bDMARD. At baseline, all patients show high disease activity (DAPSA 27.7±10.0; ASDAS-CRP 2.4±0.7). The following characteristics were notable: 1. cardio-metabolic diseases more represented in axial and polyarticular involvement; 2. baseline disease activity greater with polyarticular involvement, comorbidities, higher BMI and/or CRP; 3. patients with axial involvement showed a longer disease duration. Follow-up data are available for n.94 (74.6%) patients at T3 and n.66 (52.4%) patients at T6 evaluation, showing response in disease activity scores and patient-reported outcomes (Table 1, Figure 1). A subsequent multivariate logistic regression analysis shows that males (OR 2.53), bio-naïve (OR 4.12) and patients with high baseline CRP (OR 2.49) had the highest probability of MDA response at T6. A few patients (n.10, 7.9%) discontinued UPA during the study due to ineffectiveness (n.7) or adverse events (n.2 moderate thrombocytopenia; n.1 severe hypertension). <h3>Conclusion</h3> Preliminary data are confirming UPA effectiveness and safety in PsA real-life population. These findings will allow more targeted therapy based on patient profiling and disease domains. <h3>References</h3> [1]Coates LC et al. <i>Nat Rev Rheumatol 2022</i> [2]Mease PJ et al. <i>Rheumatol Ther</i>. 2021 <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.